EAS Blog
EAS Independent Consultants and staff provide in-depth regulatory expertise and authoritative reporting on a variety of compliance requirements for industries that EAS serves. Our experts break down complicated topics into easily understandable summaries and analysis. Subscribe to our newsletter and receive these monthly updates directly in your in-box.
Medical Device QMSR (ISO 13485)
Presented by Jeb HunterDecember 15, 2025 | 1 PM EasternIn January of 2024, 21 CFR 820 was harmonized with ISO 13485 into the Quality Management System Regulation (QMSR), a regulation that better aligns the processes and requirements for a medical device facility with international standards...
Preparing for an FDA Inspection
Presented by Jeb HunterNovember 11, 2025 | 1 PM EasternBe prepared when (not if) the FDA is at your doorstep for an inspection! This webinar will cover the processes and procedures to have in place to handle any regulatory inspections at your facility, and the set ups, best practices, and tips...
Drug and Device Corner 2025 September
REMINDER: The drug and medical device establishment registration renewal and listing certification period begins 1 October 2025. EAS is here to assist our clients with this process, do not hesitate to reach out if you need support.The agency has published their final guidance document “Alternative...
Health Canada
Interested in doing business of health products in Canada? This free webinar provides an overview of the Canadian regulation on natural health products and how EAS can assist companies with the diverse requirements of Health Canada.
FDA Announces First Use of Import Certification Authority for Certain Shrimp and Spices Potentially Contaminated with Cesium-137
October 3, 2025 Constituent Update Read on FDA WebsiteThe FDA announced today that, effective October 31, 2025, the agency will require import certification for shrimp and spices from certain regions of Indonesia, based on the risk of potential contamination of the food with Cesium-137. This...
How Do I Prevent Getting on an FDA Red List?
Importing FDA-regulated products into the U.S. can be complex. Incomplete documentation, FDA Import Alerts, placement on a Red List, and other issues can result in detentions that disrupt your business.
These disruptions lead to lost time, spoiled shipments, and unhappy customers.
But many of these issues are preventable. With the right knowledge, you can navigate the import process with confidence, avoid costly mistakes, and maintain seamless entry for your products.
Join our complimentary webinar series to learn how to master FDA import compliance from start to finish.
USDA’s Process for Auditing Equivalent Foreign Food Safety Systems
The United States Department of Agriculture (USDA), through its Food Safety and Inspection Service (FSIS), is responsible for ensuring that imported meat, poultry, and processed egg products meet the same safety standards as those produced domestically. To achieve this, FSIS’s State and International Audit Staff (SIAS) regularly audits food safety inspection systems of foreign countries deemed equivalent to the United States (U.S.).
A Guide to FSMA 204
A Guide to FSMA 204: Sorting Through the Confusion of the FDA’s New Traceability Rule for Added Food SafetyPresented by Tim Lombardo and Thomas BellSeptember 24, 2025, 1pm (eastern)The final Food Safety Modernization Act rule, the Food Traceability Rule – commonly referred to as FSMA 204 – will...
How Do I Get Removed from an FDA Red List?
Importing FDA-regulated products into the U.S. can be complex. Incomplete documentation, FDA Import Alerts, placement on a Red List, and other issues can result in detentions that disrupt your business.
These disruptions lead to lost time, spoiled shipments, and unhappy customers.
But many of these issues are preventable. With the right knowledge, you can navigate the import process with confidence, avoid costly mistakes, and maintain seamless entry for your products.
Join our complimentary webinar series to learn how to master FDA import compliance from start to finish.
HHS, FDA and USDA Extend Comment Period for Data and Information on Ultra-Processed Foods
September 18, 2025 Constituent Update Read on FDA WebsiteThe U.S. Food and Drug Administration and the U.S. Department of Agriculture are extending the comment period by 30 days for the Request for Information on ultra-processed foods. On July 24, 2025, the FDA and USDA issued a joint Request for...
Shelly Blackwell interviewed for NutraIngredients USA
Shelly Blackwell, Senior Director for Dietary Supplement and Tobacco Consulting Services at EAS Consulting Group, provided timely and practical insights in her recent interview with NutraIngredients-USA. Speaking with Danielle Masterson at the RSQ Conference, Blackwell highlighted the growing...
FDA Expert Panel on Food Allergies
The FDA Expert Panels are roundtable discussions with independent panels of scientific experts that will review the latest scientific evidence, evaluate potential health risks, explore safer alternatives, and may offer recommendations for regulatory action. This initiative is part of the FDA’s...
What Do I Need to Know About My Testing Lab?
Importing FDA-regulated products into the U.S. can be complex. Incomplete documentation, FDA Import Alerts, placement on a Red List, and other issues can result in detentions that disrupt your business.
These disruptions lead to lost time, spoiled shipments, and unhappy customers.
But many of these issues are preventable. With the right knowledge, you can navigate the import process with confidence, avoid costly mistakes, and maintain seamless entry for your products.
Join our complimentary webinar series to learn how to master FDA import compliance from start to finish.
FDA issues final guidance on using remote oversight tools to help approve drugs
FDA has issued a final guidance on how the agency intends to use alternative tools in advance, in lieu of, or in support of preapproval and prelicense inspections to remotely evaluate drug manufacturing facilities named in pending applications as part of FDA’s drug review process. FDA uses a...
FDA Detained My Product – Now What?
Importing FDA-regulated products into the U.S. can be complex. Incomplete documentation, FDA Import Alerts, placement on a Red List, and other issues can result in detentions that disrupt your business.
These disruptions lead to lost time, spoiled shipments, and unhappy customers.
But many of these issues are preventable. With the right knowledge, you can navigate the import process with confidence, avoid costly mistakes, and maintain seamless entry for your products.
Join our complimentary webinar series to learn how to master FDA import compliance from start to finish.
Heads-up: Front-of-Pack labels, GRAS changes, and supplement definition update
FDA has signaled three significant rulemakings in the Unified Agenda that could affect food and dietary supplement companies. These are not official final rules—but they’re far enough along that your regulatory, R&D, and labeling teams may want to prepare.1) Front-of-Package (FOP) Nutrition...
FDA Announces Real-Time Release of Complete Response Letters, Posts Previously Unpublished Batch of 89
September 04, 2025 FDA News Release Read on FDA WebsiteThe U.S. Food and Drug Administration today announced that it will release future complete response letters (CRLs) promptly after they are issued to sponsors. The agency also released today 89 previously unpublished CRLs issued from 2024 to...
How to Export Food from the U.S. to Mexico: A Practical Regulatory Guide
By Carolina Herrera Samaniego, EAS Consulting Group Independent Consultant As global food markets evolve, Mexico offers growing opportunities for U.S. exporters seeking to expand their international reach. Exporting food to Mexico from the United States requires more than compliant product...
FDA Releases Results on Economically Motivated Adulteration (Short Weighting) in Seafood
September 02, 2025 Constituent Update Read on FDA WebsiteThe U.S. Food and Drug Administration (FDA) is releasing the results from a sampling assignment conducted during 2022 to 2024 on testing of frozen seafood products for short weighting. Short weighting can occur in frozen seafood when the net...
FDA Urges Nicotine Pouch Manufacturers To Use Child-Resistant Packaging Following Increasing Reports of Accidental Exposure
September 02, 2025 FDA News Release Read on FDA WebsiteThe U.S. Food and Drug Administration calls on nicotine pouch manufacturers to use child-resistant packaging to protect American children from accidental, harmful exposure. From April 1, 2022, to March 31, 2025, the number of reported nicotine...
Drug and Device Corner 2025 August
Generic Drug User Fee Amendments (GDUFA) 2026 user fees were published in the 30 July 2025 Federal Register (link below). User fees are due 1 October 2025. User Fee Type FY 2026 ANDADMF $ 358,247$ 102,584 Program Large SizeMedium SizeSmall Size $ 1,918,377$ 767,351$ 191,838 Facility Domestic...
FDA to Hold Virtual Public Meeting and Listening Sessions on Food Allergen Thresholds and Their Potential Applications
August 18, 2025 Constituent Update Read on FDA WebsiteSave the Date Dates Virtual Presentations and Panel Discussions – November 18, 2025 Virtual Listening Sessions – November 19-20, 2025 Event Overview The FDA will host a three-day, virtual public meeting from November 18-20, 2025, to discuss...
Elevating Allergen Testing: Capabilities, Challenges, and the Path Forward
Food allergies are a growing public health concern, affecting millions and shaping the way food is produced, labeled, and regulated. As the regulatory landscape tightens and consumers demand safer, more transparent food options, accurate and robust allergen testing has never been more essential.
Certified Group invites you to a customer-focused webinar designed to empower food industry professionals with the latest knowledge on allergen detection. Discover cutting-edge technologies, industry challenges, and the evolving solutions that protect your brand and your consumers.
FDA Announces New FDA PreCheck Program to Boost U.S. Drug Manufacturing
August 7, 2025 FDA News Release Read on FDA WebsiteThe U.S. Food and Drug Administration today announced FDA PreCheck, a new program to strengthen the domestic pharmaceutical supply chain by increasing regulatory predictability and facilitating the construction of manufacturing sites in the United...
FDA Issues Proposed Rule to Amend Standard of Identity for Pasteurized Orange Juice
August 5, 2025 Constituent Update Read on FDA Website The U.S. Food and Drug Administration has issued a proposed rule to amend an over 60-year-old Standard of Identity (SOI) for pasteurized orange juice to promote honesty and fair dealing for consumers. The proposed rule will also provide...
Compliance Requirements for U.S. Food Products Commercialized in Mexico: NOM-051 and the Mandatory Evaluation Documents
By María Fernanda Mandujano Morales, EAS Consulting Group Independent ConsultantExporting food products from the United States to Mexico requires compliance with specific regulations—particularly NOM-051-SCFI/SSA1-2010, which governs front-of-pack and nutritional labeling for prepackaged foods and...
FDA Releases New Tool for Toxicity Screening of Chemicals in Food
July 30, 2025 HFP Constituent Updates Read on FDA WebsiteToday, the U.S. Food and Drug Administration (FDA) released its Expanded Decision Tree (EDT) chemical toxicity and risk screening tool that advances the agency’s commitment to transparency and enhancement of the food chemical safety program....
Drug and Device Corner July 2025
The FDA issued a notification on 9 July 2025 regarding an FDA Imports Review Exemption Change. The agency has rescinded the FDA review exemption that had previously been applicable to importation of certain low-value FDA regulated products. Henceforth all FDA regulated products will be reviewed...
Senators Markey and Booker Introduce Legislation to Get Dangerous Chemicals Out of Food
July 17, 2025 View Full Press ReleaseThe Ensuring Safe and Toxic-Free Foods Act of 2025 aims to enhance food safety by tightening the FDA's regulations on food chemicals. Key provisions include: Manufacturers must submit GRAS notifications for all ingredients currently marketed under "self-GRAS"...
FDA to Revoke 52 Obsolete Standards of Identity for Food Products
July 16, 2025 View on FDA WebsiteThe U.S. Food and Drug Administration today announced it is revoking, or proposing to revoke, 52 food standards after concluding they are obsolete and unnecessary. The 52 standards are for canned fruits and vegetables, dairy products, baked goods, macaroni products...